SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
FDA Recall Z-1565-2014 · Posted 2014-05-07
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Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeMAX
Date Initiated2011-12-23
Date Terminated2014-05-20
Product Quantity30 devices
Reason for Recall
It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field:
Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal.
Pin: The pin used to guide the Lock Shaft Inserter into the ma
Firm Action
Spine Frontier sent an Urgent Notification dated December 23, 2011, consignees. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached acknowledgement form. For questions call 866-914-7717
Root Cause
Device Design
Distribution Pattern
US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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